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| Name | Class |
|---|---|
| Boston University | OTHER |
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This study will test the hypothesis that a wearable automated bionic pancreas system that automatically delivers both insulin and glucagon can improved glycemic control vs. usual care for young people with type 1 diabetes 12-20 in a diabetes camp environment.
The bionic pancreas will be compared to usual care in a crossover design in which each volunteer will serve as his or her own control. Each volunteer will be under closed-loop glucose control for five days and usual camp level of diabetes care for five days in random order with a one day washout period in between.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bi-hormonal Bionic Pancreas | Experimental | Bi-hormonal Bionic Pancreas |
|
| Usual Care | Active Comparator | Usual Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bi-hormonal Bionic Pancreas | Device | Automated blood glucose control via a closed-loop bionic pancreas device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Average Blood Glucose (BG) Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) Periods as Determined From All Scheduled HemoCue Measurements With Mean Evenly Weighted Across the Daytime and Nighttime Hours. | 1 week | |
| Percentage of Time With a Low Plasma Glucose Reading (Less Than 70mg/dl) in the Bionic Pancreas Arm as Compared to Insulin Pump Arm | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Average BG as Determined From All HemoCue Measurements Taken During the Day/Nighttime Including All Extra Measurements. | Difference between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in average BG as determined from all HemoCue measurements taken during the day/nighttime including all extra measurements taken before meals, taken during exercise, and taken for hypoglycemia monitoring. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean Insulin Total Daily Dose | 1 week |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven J Russell, MD PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24931572 | Derived | Russell SJ, El-Khatib FH, Sinha M, Magyar KL, McKeon K, Goergen LG, Balliro C, Hillard MA, Nathan DM, Damiano ER. Outpatient glycemic control with a bionic pancreas in type 1 diabetes. N Engl J Med. 2014 Jul 24;371(4):313-325. doi: 10.1056/NEJMoa1314474. Epub 2014 Jun 15. |
| Label | URL |
|---|---|
| Information about this and related studies | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bionic Pancreas Then Usual Care | Subjects were campers or counselors between the ages of 12 and 21 years who had at least a 1-year history of type 1 diabetes mellitus and were receiving insulin pump therapy. In a random cross over design, subjects were assigned to either intervention (5 days on bionic pancreas) or standard care (5 days on insulin pump) with a 2 day washout period in between. |
| FG001 | Usual Care Then Bionic Pancreas | Subjects were campers or counselors between the ages of 12 and 21 years who had at least a 1-year history of type 1 diabetes mellitus and were receiving insulin pump therapy. In a random cross over design, subjects were assigned to either intervention (5 days on bionic pancreas) or standard care (5 days on insulin pump) with a 2 day washout period in between. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Cross over design, 16 participants in each arm and then switched to second arm after a 1 day washout period.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | The bionic pancreas (closed loop) will be compared to usual care (subject's own insulin pump) in a crossover design in which each volunteer will serve as his or her own control. Each volunteer will be under closed-loop glucose control for five days and usual camp level of diabetes care for five days in random order with a two day washout period in between. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference in Average Blood Glucose (BG) Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) Periods as Determined From All Scheduled HemoCue Measurements With Mean Evenly Weighted Across the Daytime and Nighttime Hours. | Posted | Mean | Standard Deviation | mg/dL | 1 week |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bionic Pancreas |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Episodes of Severe Hypoglycemia | Endocrine disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven J. Russell | Massachusetts General Hospital Diabetes Research Center | 617.726.1848 | sjrussell@partners.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 12, 2014 | Aug 10, 2017 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007333 | Insulin Resistance |
| D009120 | Muscle Cramp |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Usual Care | Other | Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump. |
|
| 1 week |
| Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Subjects With Mean BG < 154 mg/dl | Day 2-5 |
| Difference in the Percentage of Study Days With Mean CGM BG </= 154 mg/dl Over the Duration of the Closed-loop Period vs. the Usual Care Period | Day 2-5 |
| Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Hypoglycemic Events (BG <70mg/dl) as Determined From HemoCue Measurements | Day 1-5 |
| Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Fraction of Time Spent Within CGMG (Continuous Glucose Monitor) Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl) | 1 week |
| Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean BG During Exercise | 1 week |
| Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Severe Hypoglycemic Episodes and Nadir BG During Exercise | 1 week |
| Difference in Mean CGMG on Day 1 vs. Remaining Days (Days 2-5) Between Closed Loop (Bionic Pancreas Arm) and Usual Care (Insulin Pump Arm) | 1 week |
| Difference Between Closed-loop (Bionic Pancreas) and Open-loop (Insulin Pump) in Mean Continuous Glucose Monitoring Glucose (CGMG) | Day 2-5 | Day 2-5 |
| Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 70 mg/dl (Measure of Total Hypoglycemia Exposure) | 1 week |
| Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Area Over the Curve and Below 50 mg/dl (Measure of Total Hypoglycemia Exposure) | 1 week |
| Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Subjects With Mean CGMG < 154 mg/dl | 1 week |
| Difference Between Closed-loop and Open-loop in Mean CGMG in the Four Hour Period Following Meals | 1 week |
| Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean CGMG During Exercise | 1 week |
| Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Standard Deviation of CGMG Values (Glycemic Variability) in Different BG Ranges. | Difference between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in standard deviation of CGMG values (glycemic variability) in different BG ranges. %<70 70-120 70-180 %>180 %>250 | 1 week |
| Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Standard Deviation of CGMG Values at Night (11:00 PM to 7:00 AM) | 1 week |
| Difference Between Closed-loop and Open-loop in Average BG as Determined From All HemoCue Measurements Taken During the Nighttime Including All Extra Measurements Taken for Hypoglycemia Monitoring. | 1 week |
| Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Time Spent in Hypoglycemia (Plasma BG <Than 70 mg/dl) at Night | 1 week |
| Difference Between Closed-loop and Open-loop in Fraction of Time at Night Spent Within Glucose Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl) | 1 week |
| Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean CGMG at Night | Day 2-5 | Day 2-5 |
| Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Fraction of Time Spent Within CGMG Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl) at Night | 1 week |
| Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 70 mg/dl (Measure of Total Hypoglycemia Exposure) at Night | 1 week |
| Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 50 mg/dl (Measure of Total Hypoglycemia Exposure) at Night | 1 week |
| Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Carbohydrate Interventions for Hypoglycemia | 1 week |
| Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Carbohydrate Interventions for Hypoglycemia at Night | 1 week |
| years |
|
| Sex: Female, Male | Total number of participants was 32. Half were allocated to each of the 2 arms and then switched to the other arm in a random cross over design so that data was obtained from each participant for each of the 2 arms. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Percentage of Time With a Low Plasma Glucose Reading (Less Than 70mg/dl) in the Bionic Pancreas Arm as Compared to Insulin Pump Arm | Posted | Mean | Standard Deviation | percentage of time | 1 week |
|
|
|
| Secondary | Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Average BG as Determined From All HemoCue Measurements Taken During the Day/Nighttime Including All Extra Measurements. | Difference between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in average BG as determined from all HemoCue measurements taken during the day/nighttime including all extra measurements taken before meals, taken during exercise, and taken for hypoglycemia monitoring. | This data was not analysed to prevent bias. This information would have been misleading (unscheduled BG checks were performed to confirm a low BG mostly). Overall CGM trend, incidence/duration of hypoglycemia and BG trend during and after exercise is separately analyzed under other secondary outcomes. | Posted | 1 week |
|
|
| Secondary | Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Subjects With Mean BG < 154 mg/dl | Posted | Count of Participants | Participants | Day 2-5 |
|
|
|
| Secondary | Difference in the Percentage of Study Days With Mean CGM BG </= 154 mg/dl Over the Duration of the Closed-loop Period vs. the Usual Care Period | Posted | Mean | Standard Deviation | percentage of days | Day 2-5 |
|
|
|
| Secondary | Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Hypoglycemic Events (BG <70mg/dl) as Determined From HemoCue Measurements | Posted | Number | events | Day 1-5 |
|
|
|
| Secondary | Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Fraction of Time Spent Within CGMG (Continuous Glucose Monitor) Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl) | Fraction of time < 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl | Posted | Mean | Standard Deviation | percentage of time | 1 week |
|
|
|
| Secondary | Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean BG During Exercise | Data on exercise not collected | Posted | 1 week |
|
|
| Secondary | Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Severe Hypoglycemic Episodes and Nadir BG During Exercise | Individual data during exercise was not analyzed. No episodes of severe hypoglycemia were observed on bionic pancreas and only 1 episode of severe hypoglycemia occurred in usual care arm (insulin pump) | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Secondary | Difference in Mean CGMG on Day 1 vs. Remaining Days (Days 2-5) Between Closed Loop (Bionic Pancreas Arm) and Usual Care (Insulin Pump Arm) | Posted | Mean | Standard Deviation | mg/dl | 1 week |
|
|
|
| Secondary | Difference Between Closed-loop (Bionic Pancreas) and Open-loop (Insulin Pump) in Mean Continuous Glucose Monitoring Glucose (CGMG) | Day 2-5 | Posted | Mean | Standard Deviation | mg/dl | Day 2-5 |
|
|
|
| Secondary | Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 70 mg/dl (Measure of Total Hypoglycemia Exposure) | This outcome was not analyzed as we feel that the outcome "percentage of time <70mg/dl" is an equivalent indicator of hypoglycemia exposure instead of area over the curve, and can be used to compare outcomes with other studies. | Posted | 1 week |
|
|
| Secondary | Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Area Over the Curve and Below 50 mg/dl (Measure of Total Hypoglycemia Exposure) | This outcome was not analyzed as we feel that the outcome "percentage of time <50mg/dl" is a n equivalent indicator of severe hypoglycemia instead of area over the curve, and can be used to compare outcomes with other studies. | Posted | 1 week |
|
|
| Secondary | Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Subjects With Mean CGMG < 154 mg/dl | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Secondary | Difference Between Closed-loop and Open-loop in Mean CGMG in the Four Hour Period Following Meals | Data was not collected to measure this outcome | Posted | 1 week |
|
|
| Secondary | Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean CGMG During Exercise | Data not obtained for exercise period | Posted | 1 week |
|
|
| Secondary | Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Standard Deviation of CGMG Values (Glycemic Variability) in Different BG Ranges. | Difference between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in standard deviation of CGMG values (glycemic variability) in different BG ranges. %<70 70-120 70-180 %>180 %>250 | Posted | Number | Standard deviation of mean values | 1 week |
|
|
|
| Secondary | Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Standard Deviation of CGMG Values at Night (11:00 PM to 7:00 AM) | Posted | Number | Standard deviation of mean values | 1 week |
|
|
|
| Secondary | Difference Between Closed-loop and Open-loop in Average BG as Determined From All HemoCue Measurements Taken During the Nighttime Including All Extra Measurements Taken for Hypoglycemia Monitoring. | Posted | Mean | Standard Deviation | mg/dl | 1 week |
|
|
|
| Secondary | Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Time Spent in Hypoglycemia (Plasma BG <Than 70 mg/dl) at Night | Posted | Mean | Standard Deviation | percentage of time | 1 week |
|
|
|
| Secondary | Difference Between Closed-loop and Open-loop in Fraction of Time at Night Spent Within Glucose Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl) | Posted | Mean | Standard Deviation | percentage of time | 1 week |
|
|
|
| Secondary | Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean CGMG at Night | Day 2-5 | Posted | Mean | Standard Deviation | mg/dl | Day 2-5 |
|
|
|
| Secondary | Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Fraction of Time Spent Within CGMG Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl) at Night | Posted | Mean | Standard Deviation | percentage of time | 1 week |
|
|
|
| Secondary | Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 70 mg/dl (Measure of Total Hypoglycemia Exposure) at Night | This outcome was not analyzed as we feel that the outcome "percentage of time <70mg/dl at nightime" is an equivalent indicator of overnight hypoglycemia exposure instead of area over the curve, and can be used to compare outcomes with other studies. | Posted | 1 week |
|
|
| Secondary | Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 50 mg/dl (Measure of Total Hypoglycemia Exposure) at Night | This outcome was not analyzed as we feel that the outcome "percentage of time <50mg/dl at nightime" is an equivalent indicator of severe overnight hypoglycemia exposure instead of area over the curve, and can be used to compare outcomes with other studies. | Posted | 1 week |
|
|
| Secondary | Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Carbohydrate Interventions for Hypoglycemia | Posted | Number | number of interventions | 1 week |
|
|
|
| Secondary | Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Carbohydrate Interventions for Hypoglycemia at Night | Posted | Number | interventions | 1 week |
|
|
|
| Other Pre-specified | Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean Insulin Total Daily Dose | Posted | Mean | Standard Deviation | unit/kg/day | 1 week |
|
|
|
| 0 |
| 32 |
| 6 |
| 32 |
| EG001 | Control | 0 | 32 | 4 | 32 |
| Transient hyperketonemia | Endocrine disorders |
|
| Nausea | Endocrine disorders |
|
| Vomiting | Endocrine disorders |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 70-180 mg/dl |
|
| >180 mg/dl |
|
| >250 mg/dl |
|
| 70-180 |
|
| >180 |
|
| >250 |
|
| 70-180 |
|
| >180 |
|
| >250 |
|
| 70-180 |
|
| >180 |
|
| >250 |
|
| 70-180 mg/dl |
|
| >180 mg/dl |
|
| >250 mg/dl |
|